BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC LIBERTE MONORAIL CORONARY STENT

    MDR report key: 1040893 · Received May 9, 2008

    Report

    Report Number
    MW5006811
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EMERGENCY CORONARY ARTERY BYPASS GRAFT X 4 VESSELS FOR SEVERE 2-VESSEL CORONARY ARTERY DISEASE, STATUS POST UNSUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION WITH STENT REMAINING IN THE BODY OF THE RIGHT CORONARY ARTERY (99% STENOSED). THE STENT HAD COME OFF STENT CARRIER BALLOON AND WAS LODGED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE STENT REMAINS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC LIBERTE MONORAIL CORONARY STENT LIBERTE MONORAIL 4.0MM X 24MM LOX BOSTON SCIENTIFIC CORPORATION 9268372

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R